So too is the Center for Disease Control (CDC), the U.S. Department of Defense (DoD) and the Department of Homeland Security (DHS).

Instead of tossing out billions of dollars worth of drugs, such as Tamiflu and antibiotics, the U.S. Government is keeping those drugs on the shelf, secure in their efficacy despite the fact that many are years past their "expiration" date.

Why is this good news for America?

Simple: Not only does this save tax dollars, but it may also save lives.

To put a point on it: If the U.S. followed Scott Weese's advice to throw everything down the drain as soon as a manufacturer's expiration date was crossed, we might not have the Tamiflu we now need as we enter this Fall's flu season.

How many American lives might that cost?

Who knows, but with up to 90,000 deaths now predicted by the CDC due to Swine Flu this Fall, I think the number "zero" is not in the mix.

Even when told about the FDA expiration date research and the Strategic National Stockpile of drugs kept by the Center for Disease Control, Scott Weese has not bothered to find out what kind of drugs are kept, or how long they are kept for.

Here's a hint: Thousands of TONS of antibiotics and other drugs (such as Tamiflu) are kept for YEARS past their putative expiration dates.

The fact that many common drugs, including Tamiflu, pill, capsule and caplet antibiotics, are safe and effective for years past the manufacturer's suggestion, is not closely held information.

Think of expiration dates -- which the U.S. Food and Drug Administration (FDA) requires be placed on most prescription and over-the-counter medications -- as a very conservative guide to longevity....

In a study conducted by the FDA on a large stockpile of medications purchased by the military, 90% of more than 100 medications were safe and effective to use years after the expiration date. More recently, the FDA approved two-year extensions on expiration dates for a number of drugs, including the antibiotics Cipro (ciprofloxacin), penicillin, and tetracycline ....

If your medications have been stored under good conditions, they should retain all or much of their potency for at least one to two years following their expiration date, even after the container is opened.

The good news is that HHS has pre-positioned flu drugs, antibiotics, and other emergency medical supplies in 50-ton "Push Packs" around the nation. As The Richmond Times Dispatchnotes:

The Strategic National Stockpile contains medications and supplies that would be needed in a mass disaster or other emergency. Examples of emergencies include a pandemic flu outbreak, hurricanes and terrorist attacks.

The stockpile includes such drugs as the flu medicine Tamiflu and the antibiotic Ciprofloxacin, as well as medical supplies, such as those for administering drugs intravenously or for keeping a patient's airway open.

Virginia, for instance, received 280,000 treatment courses of flu drugs from the federal stockpile in the recent H1N1 swine-flu scare. The state already had nearly 800,000 treatment courses of antivirals in its own stockpile.

A stockpile can consist of drugs on hand in an existing inventory, or it can be vendor-managed inventory that a state has contracted to purchase.

According to the U.S. Centers for Disease Control and Prevention, the federal stockpile is routinely checked to make sure the items are within their recommended shelf life. That's done by making quarterly checks on some items and an annual inventory, which includes inspections of environmental conditions, security and overall package maintenance.

Now that it looks as if the stockpile drugs sent to states might not be needed anytime soon [note: this article was written in May of 2009], what happens, for instance, to the 280,000 extra treatment courses Virginia received?

States will likely get to keep the drugs, a state official said.

The shelf life of some stockpile drugs can be extended beyond their expiration date under the Food and Drug Administration's Shelf Life Extension Program. That effort started as a way for the Department of Defense to save money by not having to throw away drugs that were still usable just because the expiration date had passed.

Tamiflu has qualified for that program. Batches or lots of Tamiflu in the stockpile that meet rigorous testing standards can have the shelf life extended from five years to seven years.

When drugs from the stockpile are used, it's done under FDA Emergency Use Authorizations. The FDA issues special letters to consumers and special prescribing instructions for health-care providers.

Tamiflu is not an antibiotic, of course, but the point is even more true for pill, capsule and caplet antibiotics, which have proven shelf lives that extend for YEARS past the manufacturer-contrived or pharmacy-invented expiration date printed on the side of the bottle.

As Dr. Francis Flaherty, Director of the U.S. FDA's expiration testing program noted a few years back:

"Manufacturers put expiration dates on for marketing, rather than scientific, reasons. It's not profitable for them to have products on a shelf for 10 years. They want turnover."

In short, short expiration dates are, for the most part, little more than a scam.

[Strategic National Stockpile] efficiency measure is focused on reducing the cost of replacing inventory by extending the shelf life of products that remain efficacious after their original manufacturer's expiration date through a Shelf Life Extension Program (SLEP). By extending the shelf-life of a product, the program does not need to spend money to replace that product as quickly or as often. The program's assets now include large amounts of antibiotics that cannot be rotated back into the market and chemical/nerve agent with no commercial use. Where possible, the program rotates stock in the market to avoid expiration of supplies through its vendor managed inventories. ... The program's annual efficiency measure is dollars saved per dollar invested in the Food and Drug Administration's Shelf Life Extension Program (SLEP) for available projects.

The Shelf Life Extension Program (SLEP) has found that cipro, a common pill antibiotic, is good for more than seven years past its putative expiration date.

Doxycyclin, amoxycillin, penicillin, and cephalexin are similarly long-lived if kept in a medicine bottle at normal room temperature.

The National Institute of Health notes that the U.S. Department of Health and Human Services has a contract with Bayer, the maker of Cipro, to rotate its stock every three years -- two years longer than the expire date you will find on the same drug if you buy it at your local pharmacy.

This last point is not a small matter.

I find it hard to believe that Scott Weese does not know the difference between a manufacturer's expiration date (2-3 years) and the even more bogus date put on by dispensing pharmacies (typically 6-months or a year) which are designed to get patients to toss good medicines down the drain even faster.

I am going to be charitable here, however, and assume ignorance rather than malevolence.

2 comments:

I'd venture to guess that the expiration dates pharmacies put on prescriptions are also to protect people from themselves, in a way. I can see someone taking an antibiotic and stopping because the symptoms went away, so there's some left over. And then, when symptoms do come back some time later, they think "Oh, this helped, I'll just pop one of these." And then you have someone who's on the way to producing some pretty antibiotic-resistant drugs in their system.

Of course, idiots abound everywhere and I'm sure for everyone who treats antibiotics like ibuprofen and just pop one when needed, there more who use them as directed.

In the context of what I was writing about antibiotics used to treat animal bites, expiration dates has nothing to do with anything.

Go to this page (see >> http://www.terrierman.com/antibiotics.htm ) and look at the graphic at top.

Any question about what I am treating in the context of working terriers?

I don't think so!

Notice the top 3 instructions:

1) Use the right drugs;

2) Give the right dose;

3) Keep the dog on the medicine long enough.

I repeat this advice later on and detail dosage, etc.

Scott Weese is not arguing type of drug, quality of drugs, dosage, or duration of time the drug is given. There is a reason for that; I am 100% right on all points.

On the one point he has decided to argue (expiration dates for re-purposed human antibiotics), he is simply 100% wrong.

For the record, and because Gina asked, Scott Weese ripped me hard without contacting me. His was the first shot fired, and it was done without notice and without doing the most basic kind of research.

I set him straight in a comment on his blog, giving him time to clear it up and clean it up.

He them replied, saying something that proved he had not even bothered to read the citations and links given to him. His line was that the Harvard medical letter and WSJ article said expired antibiotics were not poison when expired, which is NOT what the Harvard or WSJ articles said -- they said that most expired drugs were still efficacious, which is why Uncle Sam was keeping a billion dollars worth of drugs on the shelf. I corrected him, and the comment was ignored and not posted.

I then blogged for the first time, and moved on.

He then came back with more nonsense today, and I roundhoused him a second time.

Scott Weese simply has no idea at all about drug expiration, manufacturing, or marketing. I have not called him corrupt, merely ignorant in an area he really needs to NOT be ignorant in, especially if he wants to put himself out there as an expert in zoonotic disease.

I live and work in Washington, D.C. where September 11 is more than a date, and where anthrax in the mail has actually killed people. In that context, following advice from people like Scott Weese is more than expensive; it is potentially deadly.